Sutures are used in a variety of surgical applications to hold skin, internal organs, blood vessels or any other tissue together, after they have been severed by injury or surgery. Daring a standard suturing procedure, the sharp end of a curved suturing needle is passed through the tissue and the needle is pulled through manually. Manual suturing requires the use of both hands, which can block the surgical field of view. Further it involves direct handling of a sharp suturing needle usually with forceps which can result accidental slipping and needle-stick injury to the surgeon. For example, manual suturing with the straight Keith needle lends itself to even less needle control and increased risk of inadvertent needle-stick injury, especially to the inexperienced user. Needle-stick injury poses significant health risks to the surgeon because of the potential exposure to blood-borne pathogens such hepatitis virus or HIV. Lack of control of the suture needle can also lead to injury to the patient through inadvertent injury to surrounding tissues, vessels, and nerves. For example, when securing central venous access devices with a suture to the skin, poor needle control can lead to injury to the carotid artery, external jugular vein, internal jugular vein, nerves, and/or to the catheter itself.
Current designs of suturing devices that attempt to overcome these issues are extremely complex and bulky. For example, the device disclosed in 2002/0193809 describes a needle encased in a cartridge that does not permit good visualization of the surgical field. It also fails to fully protect the operator from accidental needle-stick injury.
For the forgoing reasons, there is an unmet need for devices that are simple to operate and can be manufactured inexpensively. In particular there is an unmet need for a suturing device that can be operated using one hand while also providing improved safety of operation.